Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as Commissioner of the Food and Drug Administration. As part of the hearing, Gottlieb was questioned on an array of topics from his prior service at FDA to his alleged financial interests in pharmaceutical companies. He was also asked to comment on a number of issues relating to food safety, labeling, and the overall approach that he envisions for FDA as a public health agency. Highlights of his responses on those issues are below.
On FSMA Implementation: Gottlieb considers FSMA to be necessary to ensure the safety of the nation’s food supply and stated that he plans to protect and promote public health as Congress intended when writing the law. As regular readers of our blog know, food safety and the federal GMO labeling law have been rare examples of bipartisan cooperation in recent years.
On Understanding the Financial Demands on Industry: Gottlieb was asked whether he would ensure that proper guidance is available for implementation of the recent revisions to regulations governing nutrition facts labeling and whether he would consider postponing the deadline for new labels. He was not specific about the possibility of extending the compliance date. However, he did note that:
I’m philosophically in favor of trying to make sure we do these things efficiently not only because it imposes undue costs on manufacturers if they’re constantly updating their [nutrition facts] labels but we also have to keep in mind it causes confusion for consumers if the labels are constantly changing, so you want to consolidate the label changes . . . as a matter of public health so the information is conveyed accurately and efficiently to consumers. So this is something that I do care about and I look forward to working on it if I’m confirmed.
Gottlieb’s remarks demonstrate a welcome acknowledgment of the extensive compliance costs associated with revisions to nutrition labeling requirements, and the capacity to lessen the regulatory burden on industry by streamlining changes and providing guidance to industry on how to comply.
On Commitment to Science-Based Policies: Gottlieb assured senators he would take a science-based approach and would study issues raised related to genetically modified fish and guidance on seafood consumption for pregnant and nursing women. The FDA most recently issued advice in January 2017 that ranked fish in terms of its safety of consumption for expectant mothers with special attention to the amount of mercury. The guidance, however, did not address the effects of other contaminants, as well as the nutritional benefits of fish, which has created confusion among consumers because the agency’s initial guidance in 2014 was different.
On Antibiotic Resistance: Gottlieb referred to his time as a physician and the loss of patients to antibiotic-resistant infections to express his understanding of the ongoing problem. He recognized that congressional statutes have been the driving force behind the FDA taking steps to address the issue, both on the development side and with the use of anti-infectives in animal feed. The use of antibiotics in animals can allow resistant bacteria to contaminate the food supply, which makes the study of anti-infectives in animal feed all the more crucial in deterring the rise of antibiotic resistance.
The Senate has a two-week recess, which means they likely will not vote on this nomination until the week of April 24. Gottlieb’s nomination is expected to be confirmed.